Gilead’s Kite announces results from 5-year follow-up study of Yescarta in NHL

The company states: “Kite, a Gilead (GILD) Company, announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta in patients with relapsed/refractory non-Hodgkin lymphomas, or NHL, including follicular lymphoma or marginal zone lymphoma. The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. The data were shared in an oral presentation during the 66th American Society of Hematology Annual Meeting and Exposition. In ZUMA-5, 159 patients were enrolled. At a median follow-up of 64.6 months (range, 32.3-81.4; FL: 65.7, MZL: 55.8), the overall response rate was 90% and the complete response, CR, was 75%. Among patients who achieved a CR, 58% remained in CR at the time of data cutoff. The median duration of response was 60.4 months with estimated 60-month DOR of 53.4%. Median progression-free survival, PFS, was 62.2 months. PFS rates at 60 months in patients with FL were consistent regardless of high-risk characteristics. Median time to next therapy was NR in all patients with NHL (95% CI, 38.6-NE; consistent by disease type), with a 60-month estimated rate of 53.3% (95% CI, 45.0-60.9; FL: 54.0%, MZL: 50.9%). At data cutoff, 55% of patients (n=87) were alive with no new anticancer therapy. The median overall survival, OS, was NR, and the 60-month OS estimate was 69.0% (95% CI, 60.8-75.8; FL: 68.9, MZL: 71.1). No new Yescarta-related safety signals emerged in the five-year analysis. One patient progressed after the data cutoff of the four-year analysis and no patients died of disease progression after the prior analysis. Among treated patients (n=152, 124 FL, 28 MZL), three new events not related to Yescarta were reported after the four-year analysis, including Grade 3 metastasis, Grade 1 bladder cancer, and Grade 4 myelodysplastic syndrome (a serious adverse event). One patient died of pneumonia, unrelated to Yescarta. At any time on trial, a total of 46 patients died, due to progressive disease (n=14), secondary malignancies (n=6), infections (n=11), or another or unknown cause (n=15).”

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